DISPOSABLE ADHESIVE SURFACE ELECTRODES, DISC ELECTRODES— 510(k) K073532
Substantially EquivalentTechnomed Europe
FDA 510(k) clearance K073532 for DISPOSABLE ADHESIVE SURFACE ELECTRODES, DISC ELECTRODES, Substantially Equivalent on 2008-05-01. Applicant: Technomed Europe. Device class: 2.
Clearance details
- Applicant
- Technomed Europe
- Product code
- Code GXY
- Device class
- Class 2
- Regulation
- 21 CFR 882.1320
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Maastricht-Airport, NL
Recent devices under product code GXY
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- K260578 — Ambu® NeurolineTM Cup MRI/CT (Models 72704/21US, 72704/23US, 72704/25US, 72704/27US) Ambu® NeurolineTM Cup MRI/CT-set (Models 72704/21-1010US, 72704/21-1010US, 72704/23-1010US, 72704/25-1010US, 72704/27-1010US) Ambu® NeurolineTM Cup MRI/CT-mini set (Models 72704/21-0301US, 72704/23-0301US, 72704/25-0301US, 72704/27-0301US)
- K261442 — Charlotte ACC25 Surface Electrode Array; Charlotte ACC25 Reusable Surface Electrode Array
- K261522 — BioWave BioWraps
- K253237 — Elde Medical Electrodes (T5/ 5 cm x 5cm electrode T10/ 5 cm x 10cm electrode)
More clearances from Technomed Europe
view all- K254183 — MR Conditional Cup Electrodes
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- K241045 — Disposable Subdermal Needle Electrode, Corkscrew
- K130136 — DISPOSABLE AND REUSABLE CONCENTRIC NEEDLE ELECTRODES,DISPOSABLE AND REUSABLE SUBDERMAL NEEDLE ELECTRODES,
- K121257 — LARYNGEAL ELECTRODE
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